Testing Therapies Less Effective than the Best Current Standard: Ethical Beliefs in an International Sample of Researchers
Design: Using a web-based survey, we presented a hypothetical scenario proposing to test a therapy for HIV disease ("therapeutic inoculation") known to be less efficacious than highly active antiretroviral therapy (HAART). Respondents evaluated various trial designs as ethical or unethical.
Participants: 604 subscribers to two listservs for individuals interested in international health research ethics.
Main outcome measures: Proportion of respondents endorsing trials testing this "substandard" therapy, and proportion endorsing placebo-controlled trials.
Results: There were 215 respondents from 47 countries. Forty-five percent of respondents were from low or middle income countries; 96% devoted at least some time to research activities; and 75% had "some" or "considerable" research experience in developing countries. Of respondents, 97% (95% CI 94.7 to 99.4) endorsed testing therapeutic inoculation, without HAART, in patients with HIV disease; 86% (95% CI 81.4% to 90.7%) endorsed testing against placebo. Sixty-eight percent explicitly endorsed principles where the standard of care for subjects in clinical trials is determined by local, not universal, standards. There were no differences in responses based on respondent education-level or the income-level of their country of citizenship.
Conclusion: There was broad agreement that a therapy of potential local benefit may be tested, even when that therapy is known to be inferior to the standard of care in wealthy countries. Most agreed that a placebo control may be used in some circumstances.
Document Type: Research Article
Affiliations: 1: Tufts-New England Medical Center, Boston, USA 2: Tufts-New England Medical Center, Boston, USA; Africa Centre for Health and Population Studies, Mtubatuba, South Africa 3: Harvard School of Public Health, Boston, USA 4: University of Rochester School of Medicine and Dentistry, Rochester, USA
Publication date: 01 June 2003